The study, which was started in 2011, follows a year of federal investigation on Medtronic’s payment of authors who wrote studies on Infuse.

The investigation turned up no wrongdoing on the company’s part, but a set of 12 recently filed lawsuits against Medtronic in May, filed on behalf of a group of patients who were treated with Infuse, has the company preparing to defend itself again. Infuse was developed and is sold from the company’s Memphis-based spinal division.

Company officials couldn’t go into specific details of the lawsuits, but released a statement standing behind Infuse and preparing to “vigorously defend it in court.”

“Since the product was approved in 2002, Medtronic has communicated the risks of Infuse through our FDA-approved package insert,” the statement said. “Patient safety is our top priority, and Infuse Bone Graft has been found to be safe and effective by the FDA for specific uses in the spine. Medtronic strongly believes that the safety profile reported to the FDA and detailed in product labeling support the continued safe use of Infuse Bone Graft for approved indications.”

The Yale report stated that Infuse “poses certain risks” that require evaluation by patients and doctors. However, the company reported risk information to the FDA before the product was approved in 2002.

“Through this open access process coordinated by Yale, we provided an unprecedented level of data access in order to test new approaches to data sharing of industry research,” Omar Ishrak, chairman and CEO of Medtronic, said in a statement. “We recognize that our products and therapies must have the public and medical community’s trust, so we will continue to create, test and explore new ways to make our clinical research available as part of our commitment to transparency and to providing information that informs the medical decisions that physicians make based on each patient’s needs.”

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